TNX-102 SL: A Promising Breakthrough in Fibromyalgia Treatment

December 19, 2024

Sonam Bojjapally

Fibromyalgia is a chronic pain disorder that causes pain, tiredness, and sleep problems. It is more prevalent in women and is estimated to affect more than 10 million adults in the United States. The management of fibromyalgia is still an issue of concern as there are no new drugs that have been approved for its treatment for more than fifteen years. The New Drug Application (NDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is a non-opioid and centrally acting analgesic for use at bedtime has received the due acknowledgment of the U.S Food & Drug Administration (FDA).

The NDA for TNX-102 SL is backed by data from the results of two Phase 3 clinical trials: RELIEF ClinicalTrials.gov number-NCT04172831 and RESILIENT number-NCT05273749. These were double-blind, placebo-controlled studies to assess the therapeutic efficacy and safety of 5.6mg TNX-102 SL once at night for 14 weeks.

The primary outcome in the RELIEF trial involved a change in pain, where patients recorded their weekly average daily pain scores in a diary. Secondary endpoints were quality of sleep, fatigue, and the fibromyalgia syndrome-specific global rating of symptoms and overall functioning. The RESILIENT trial was designed as a confirmatory trial, using the same approach as RELIEF to validate the outcomes on a larger scale. The results from the RELIEF trial showed the superiority of TNX-102 SL in comparison with placebo in terms of the reduction of pain intensity scores.

In RELIEF trial findings the primary endpoint results showed that the effect of TNX-102 SL 5.6 mg on data compared positively with placebo in terms of the weekly average pain score, with least square (LS) mean (95% Confidence interval (CI)) of -1.91 (-2.15, -1.68) compared to -1.51 (-1.74, -1.28) for placebo, P = 0.01. The exploratory analysis showed a total of 46.8% of the patients who received TNX-102 SL experienced at least a 30% decrease in daily pain compared with 34.9% of the placebo group (Odds Ratio (OR) 1.67, 95% CI 1.16-2.40; P = 0.006). The secondary endpoints have shown an enhancement in sleep quality, fatigue, and overall fibromyalgia-related symptoms and functioning.

In RESILIENT trial findings the primary endpoint results showed the reduced weekly average severity scores of fibromyalgia symptoms of TNX-102 SL patients compared to the placebo group were shown (LS mean difference was -0.7, P = 0.00005). The secondary endpoints have noticed improvements in overall sleep, fatigue, and global functional state.

In both trials, it was demonstrated that TNX-102 SL is safe and the side effect of temporary tongue or mouth numbness, which was seen in more than half of the subjects, was mild and did not cause treatment to be terminated.

The approval of the NDA for TNX-102 SL will be considered a major step forward in the management of fibromyalgia. Dr. Seth Lederman, CEO of Tonix Pharmaceuticals has emphasized the importance of this development: “This has been a clinical delight for the fibromyalgia community who have been waiting for a new drug for over 15 years. TNX-102 SL can fill this gap and offer patients a safer effective treatment solution.” He also mentioned that the FDA granted fast track to the drug in July 2024 thereby meeting an important medical need.

TNX-102 SL is now under the process of reviewing the regulatory approval with the acceptance of the NDA. It is expected that the FDA responds with a Prescription Drug User Fee Act (PDUFA) of target action date on the Day 74 Letter, which will also declare whether the drug is given priority review.

TNX-102 SL is considered a promising tool of relief for millions who are affected by fibromyalgia. A strong body of evidence supporting efficacy and safety from the RELIEF and RESILIENT trials will help bring closure to the treatment gap that this chronic disease has left many patients to endure for years. If approved, we will have it as the first fibromyalgia new drug entry since the year 2000 and it will be the pioneer of a new generation of non-opioid analgesics. The fibromyalgia community is still waiting for an FDA decision. TNX-102 SL is ready to revolutionize fibromyalgia treatment and help change the lives of millions of people.

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